Breast Implants Public Forum: Concerns about Health Canada's Process

Note that the deadline for registering to present at the
breast implant hearings in Ottawa on Spet 29 has been extended to
September 16th. Go to
Breast
Implants Public Forum for more details.

Letter #1

Toronto
July 29, 2005

(sent via Breast Implant Forum website)

To Whom It May Concern

Having looked over the site for the breast implant forum and read the "Affiliation
and Interest Summary" for the panel members, I have a question for which
I cannot find an answer on the site. Three of the panel members have identified
competing interests in terms of their affiliations with the manufacturers whose
submissions are before them (Inamed, Mentor ). How will this be treated by
Health Canada ? Will they have a different status from the other members? Will
they be required to remove themselves from the group for certain parts of the
discussion?

Your prompt response to this query would be greatly appreciated. Please reply
to me as well as to Dr. Abby Lippman who is cc'd on this message.

Guidance on conflict of interest is provided to potential members when
discussing the appointment. Before appointment, all potential Panel members
are required to submit conflict of interest declarations to disclose to
Health Canada any circumstance that may place, or be seen to place, the
member in a real, apparent or potential conflict of interest. All Panel
nominees are screened for perceived, potential or real conflicts of
interest in accordance with Health Canada 's Conflict of Interest Policy.

The membership of the Expert Advisory Panel on Breast Implants as a whole
covers areas of relevant expertise and knowledge such as chemistry,
materials engineering, radiology, epidemiology, plastic/reconstructive
surgery, psychology, ethics, rheumatology, toxicology, surgical oncology
and patient needs and experience.

The Panel members have been selected according to three core principles:

They are experts in their field, with expertise
and experience that are vital to the ability of the panel to
provide high-quality advice;

They have pledged to be objective: they will
listen to the evidence presented and keep an open mind;

They have no vested interest in the panel outcome.

In seeking out a high level of expertise in issues such as those under
examination by the panel, it is not unusual to find individuals who have had
relationships of varying types with the product manufacturers. The expert
community in Canada is a small one and the expertise that Health Canada has
gathered for this panel is in high demand. Experts who are leaders in
their fields or who possess unique combinations of expertise and experience
are often asked to provide advice to various organizations, including non-government
organizations, governments and drug manufacturers. To obtain the advice or
participation of experts, manufacturers frequently
cover the costs associated with travel and other expenses.

Several of the members of this panel have provided advice to, or have
participated in conferences or activities sponsored by the product
manufacturers. Panel members were selected to provide an appropriate
balance of views on the panel. They were specifically asked to declare
this type of information, affiliation or activities, as set out in the summary
of each member's information posted on the Health Canada website. Other panel
members have spoken publicly about issues related to the safe use of breast
implants.

When deciding to include a panel member who may be, or may be perceived to
be, in a conflict of interest situation, Health Canada considers the following:

- the panel has an advisory function only ? Health Canada makes the
decision;
- a panel member is only one voice among many on the panel;
- the panel member has to disclose any affiliation or potential
conflict of interest to the Chair of the panel who can take action if a
member advocates a biased position during the discussions.

In addition to screening at the time of the appointment, at the opening of
the meeting there is a round table declaration and discussion of the panel's
conflict of interest and acceptance of the Terms of Reference as written. In
situations where conflict of interest, or the appearance thereof, arises in
the course of the work of a Panel member, the individual involved must declare
its existence. It is the role of the Chair to manage the Panel's deliberations
in light of conflict of interest that has been disclosed. This includes
resolving differences that may arise during the meetings, ensuring that Panel
members are given adequate opportunity to provide opinions addressing questions
posed by Health Canada , seeking to
achieve consensus and ensuring if consensus cannot be reached, it will be reflected
in the Record of Proceedings with no attribution to Panel members. The
Chair must also ensure the Record of Proceedings sufficiently captures the
discussion of the day and provides clear advice to Health Canada .

I hope this addresses your concerns.

Sincerely,
Hripsime Shahbazian

cc: Abby Lippman

Revised: August 8, 2005

Letter #2

Toronto
August 29, 2005

Dear Ms. Shahbazian

Thank you very much for your response (sent via Ms. Chantal Tremblay) to my
earlier questions about the breast implant panel process, specifically relating
to conflict of interest of panel members. A few additional questions have arisen
as our group moves ahead in preparing for the hearings.

1) Timelines for response We have concerns about the very short turnaround time for individuals
wishing to prepare a thorough and thoughtful response to complex scientific
questions. Your site states:

"Please note the following important deadline : The
last day to register to present in person to the Expert Advisory Panel is Friday,
September 9, 2005 . All the written and on-line input received at
that date will be submitted to the Panel members. You are welcome to provide
input past September 9th so it can be shared with others on the website.
This information will be reviewed on-line by the Panel members at their discretion "

By this we understand that if interested individuals want to have input into
the process that is anything more than the allowed 3 minutes on September 29,
and that is guaranteed to make its way to the panel members, they must submit
their commentary by September 9. And yet, to date (August 29) we have not yet
seen the details of just what it is we are being asked to comment on. Indeed,
we do not even know which products are under consideration. Presumably, the
manufacturers will be supplying the public with information about the products
in question, but nowhere on your site does it tell us when to expect that information.
How can citizens be expected to provide substantive responses when at less
than two weeks before the deadline, nothing about the products under review
is up on the site?

2) Limitations of expected responses The website provides a series of questions limited to the safety
and effectiveness of silicone gel breast implants: preclinical data, clinical
data and labelling. We understand that these are the areas that are mandated for
consideration through the Food and Drugs Act and Medical Devices
Regulations . And yet, as Health Canada staff and members of the
panel are aware, discussions of these implants "in the real world" are
taking place against a backdrop of concern about healthy body image, within
much larger population health and women's health discourses. Are experts
in the fields of sociology, psychology, psychiatry and gender studies - with
important information to offer for the panel's consideration - expected to
constrain their input to conform to these limitations? We would expect not,
though this is not clear from the information on the site. What assurances
does this much larger body of experts have that their input will be heard
equally by the panel and by Health Canada ?

3) Issues relating to in-person presentations i) We understand that those who request to make presentations must
confine their oral delivery to a maximum of 3 minutes. Time restrictions
are understandable in the event that a large number of people come forward
wanting to present and, presumably, the time allotted has been based on calculations
of an expected number of applicants and a reasonable amount of time that
panel members can be expected to sit. If the numbers are lower than expected
once the Sept 9 deadline for registration has passed, is there any chance
this time restriction might be loosened? Frankly, we find it unfathomable
how a learned expert in any field could say anything meaningful about this
complex scientific and social issue within such a short timeframe.
ii) Are any provisions being made to cover travel and accommodation expenses
for those registering to present? While we realize that participants may not
need to stay in the same hotel that the hearings will be taking place in, it
would be convenient to be on site; we find it regrettable that the venue chosen
is one of the most expensive hotels in Ottawa .

4) Who can present It is noted on the website that "priority will be given to
presenters who are Canadians and residents of Canada ." While we support
this focus within reason, we would be disappointed if the intelligence on
this issue from other countries was completely lost in the process. Can you
explain more clearly what this means for non-Canadians who wish to present?
For example, is it conceivable that if large numbers of Canadians come forward
to register, possibly no non-Canadians will be allowed to present, and how
will that decision be made? If non-Canadians submit written input before
September 9, will their input be passed on to the panel members for their
deliberations?

Thank you for your consideration of our questions. We hope to hear back from
you soon.

Response from Health Canada to Letter #2

Ottawa
September 13, 2005

Dear Ms. Rochon Ford,

Thank you for your correspondence of August 29, 2005 . Health Canada is
happy to have the opportunity to provide further clarification to the
issues you have raised regarding the public forum process on silicone
gel-filled breast implants. Please find enclosed responses to your
questions:

1. Timelines for response
Health Canada received the manufacturers' information on September 12 and
now that information is available on the HC website. Provision of this
information by the manufacturers is voluntary. Health Canada appreciates
that the public may need additional time to assess this information and has
therefore extended the following deadlines:

In-person presentation to the Expert Advisory Panel:
- Deadline for registration has been extended to Friday, September
16, 2005 .
- Deadline for presenters to provide Health Canada with their
final presentation and other material: September 21, 2005

On-line or in writing input to the Expert Advisory Panel:
- Deadline for submitting input on-line or in writing is September
21, 2005, in order for it to be provided to the panel for their review.
- Input received after September 21, 2005 will be shared with
others on-line and will be reviewed on-line by panel members at their discretion.

The above information was posted on the Health Canada website on September
9th, 2005

2. Limitations of expected responses
The public forum process is designed to provide an equal opportunity to
speak and input to all those who have expressed an interest in
participating. The Panel is mandated to provide advice on the questions
posed by Health Canada and the public is encouraged to address the same
questions in their input. However, the Panel will hear all relevant
information on this issue and take it into consideration in its final
recommendation to Health Canada .

3. Issues relating to in-person presentations
i) Health Canada anticipates having a considerable number of registered
participants by September 16th which will not allow us to change the time
limit for the public presenters. However, public presenters who wish to
provide additional information to the Panel, apart from their presentation
slides, can do so by submitting their material in writing by September 21st
deadline.

ii) We regret to inform you that Health Canada is not resourced to cover
any travel related expenses for the registered participants. Members of the
public, who cannot participate in person, can provide their input via the
written ( paper or on-line) consultation process. This strategy will allow
for a broad range of the Canadian public to participate and provide their
views.

4. Who can present
In order to maintain the focus of the Public Forum on the Canadian context,
priority will be given to Canadian presentations. This means that any
non-Canadian will be confirmed as presenters after all Canadian registered
participants are accommodated. However, non-Canadians can provide their
input on-line and if received prior to September 21st, it will be forwarded
to the Panel members for their consideration.

The public forum is a relatively new practice for Health Canada and a
learning experience for all involved. Health Canada is committed to
openness and transparency in its decision-making process and, as we
progress towards that goal, we will evaluate the Expert Advisory Panel
meeting and public forum. Lessons learned will contribute to the current
policy development work that the Department is undertaking on this type of
public involvement mechanism. We would welcome input from you as part of
this evaluation process.

I trust you will find that the information provided in this letter
addresses your questions. Please do not hesitate to contact me at 946-4629
or Susan Gardner-Barclay, OCAPI's Director General at 946-6540, should
you
have any further questions.